SCI-110 in the Treatment of Tourette Syndrome
ConditionTourette Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeurothera Labs Inc.
About this trial
To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.
Eligibility criteria
Qualifiers
Tourette syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
Male and female subjects with an age between ≥18 and ≤65 years
Total tic score (TTS) of the revised Yale Global Tic Severity Scale (YGTSS-R) >14
Clinical Global Impression-Severity Score (CGI-S) ≥4
Disqualifiers
Comorbid obsessive-compulsive disorder (OCD), attention deficit/hyperactivity disorder (ADHD), depression, and anxiety disorder when unstable or in need of an initial adjustment for a therapy-according to the investigator's judgment
Presence of severe psychiatric conditions such as developmental disability, psychotic illness and bipolar disorder- according to the investigator's judgment
Ongoing behavioural treatment for tics
History of schizophrenia, seizure, psychotic, severe personality, or pervasive developmental disorder
Trial design
Treatments tested in this trial
- SCI-110
- Placebo
Treatment groups
164 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov